# K132393: Cercom II Cement

- Pathway: 510(k) (Traditional)
- Applicant: Denali Corporation
- Decided: Mar 14, 2014 after 225 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cercom Cement/Denali Corporation: named in the summary without a submission number
- (no number) RelyX Cement/ESPE/3M: named in the summary without a submission number
- (no number) Variolink Cement/Ivoclar: named in the summary without a submission number
- (no number) Calibra Cement/Dentsply: named in the summary without a submission number
- (no number) Nexus Cement/Kerr: named in the summary without a submission number

## Most influential descendants
- K141503: Denali 501CEMENT (2014), 0 descendants of its own

## Indications for use
CERCOM 11 Cement Is a sell-adhesive cement recommended for the bonding of ceramic, metal and composite restorations.

Source page: https://510kreport.com/device/K132393
Methodology: https://510kreport.com/methodology